FDA.reportPublic FDA data

Cold and Flu

Product NDC
0363-4278
11-digit product format
003634278
Labeler code
0363
Product ID
0363-4278_78e1d1c2-fcf4-46e5-8e3c-4916498fc52d
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl, Triprolidine HCl
Dosage form
KIT
Labeler
Walgreen Company
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-10-21
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Cold and Flu
Brand name suffix
Daytime Nighttime Severe
Listing expiration
2027-12-31

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-4278-45Cold and FluDaytime Nighttime Severe1 in 1 PACKAGEKIT13
0363-8078-45Cold and FluDaytime Nighttime Severe177 mL in 1 BOTTLE, PLASTICSOLUTION177 mL650 mg in 20mL3
0363-9042-45Cold and FluDaytime Nighttime Severe177 mL in 1 BOTTLE, PLASTICSOLUTION177 mL400 mg in 20mL3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-4278COLD AND FLU DAYTIME NIGHTTIME SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, TRIPROLIDINE HCL) KIT [WALGREEN COMPANY]2Current NDC, 3 package rows20241027_afbe932c-c26a-4fac-9ea3-d050db01eded.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 28 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucinex Childrens Stuffy Nose and Chest CongestionGUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC7354f57c-0ecf-481f-9482-0040c90c43502026-05-18WarningsExact identifier
application number: M012
Mucinex Childrens Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC5bda415d-739f-4ca5-b5b2-07c14a81863b2026-05-18WarningsExact identifier
application number: M012
Mucinex Childrens Multi-Symptom Cold and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC8f3eb5c5-832e-4806-b3da-ef112cf55dcf2026-05-18WarningsExact identifier
application number: M012
Mucinex Childrens Day Time Multi-Symptom Cold and Night Time Multi-Symptom ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, AND DIPHENHYDRAMINE HYDROCHLORIDEReckitt Benckiser LLCe3aea6df-37a4-43c5-a192-a902cbff3f922026-05-18WarningsExact identifier
application number: M012
Mucinex Childrens Cough and CongestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCd9e5a8d7-814c-4ab1-bb05-e4cb9155978e2026-05-18WarningsExact identifier
application number: M012
Mucinex Childrens Day Time Multi-Symptom Cold and Mucinex Childrens Night Time Multi-Symptom Cold Triple PackACETAMINOPHEN, DIPHENYLHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESINReckitt Benckiser LLCc7ab5201-8550-4bf4-957c-c8f049aeaa4a2026-05-18WarningsExact identifier
application number: M012
Mucinex Childrens FreeFrom Multi-Symptom Cold and Flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC84e7be8f-2785-45ef-9c44-de05394fcd992026-05-18WarningsExact identifier
application number: M012
Mucinex Childrens Multi-Symptom ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC771d7fd8-184f-48a3-90ed-e8f00159d97e2026-05-18WarningsExact identifier
application number: M012
MUCINEX Childrens Stuffy NoseOXYMETAZOLINE HYDROCHLORIDEReckitt Benckiser LLCde1c0abd-1644-4351-8106-e9df6ca5c1422026-05-18WarningsExact identifier
application number: M012
Mucinex Childrens Fever Sore Throat and CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLC1538a75d-582a-9501-e063-6394a90a6c552026-05-18WarningsExact identifier
application number: M012
Mucinex Fast-Max Kickstart Severe Congestion and Cough Maximum StrengthDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINReckitt Benckiser LLC19105007-0193-0764-e063-6294a90a01a42026-05-18WarningsExact identifier
application number: M012
Mucinex Fast-Max Kickstart Severe Congestion and Cough and Mucinex Fast-Max Nighttime Cold and FluDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, ACETAMINOPHEN,TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC34fd2458-9acd-cdf7-e063-6394a90a3d0a2026-05-18WarningsExact identifier
application number: M012
MUCINEX FAST-MAX NIGHTTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC3a24b06c-00a6-c2ef-e063-6294a90a4d722026-05-18WarningsExact identifier
application number: M012
Mucinex Fast-Max Severe Congestion and Cough Maximum StrengthDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINReckitt Benckiser LLC14be3ab0-d6ae-e342-e063-6294a90ab8512026-05-18WarningsExact identifier
application number: M012
BanophenDIPHENHYDRAMINE HCLBryant Ranch Prepack20f00537-2c8a-45d1-8e5f-ec276d0a47b62026-05-18WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLL.N.K. International, Inc.38df2308-f6f9-4476-ad34-4b5bc5f9fdf22026-05-18WarningsExact identifier
application number: M012
Allergy Plus Headache ReliefACETAMINOPHEN, DIPHENHYDRAMINE HCLWALMART INC.88e3b969-79d0-4e64-95c0-c5cfd41e365f2026-05-18WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLL.N.K. International, Inc.db264d2f-bf81-4da2-8595-2bfa1e4ba2f12026-05-18WarningsExact identifier
application number: M012
equate nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores Incb8fc9b0e-8ab7-46e6-9fd9-18f8d4a14b5c2026-05-15WarningsExact identifier
application number: M012
good neighbor pharmacy cold and coughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLAmerisource Bergenda91e6b6-32ff-44fd-afce-33ea9549554b2026-05-15WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2637727{1 (acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution) / 1 (acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / phenylephrine hydrochloride 0.5 MG/ML / triprolidine hydrochloride 0.125 MG/ML Oral Solution) } PackGPCKafbe932c-c26a-4fac-9ea3-d050db01eded3
26377271 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 10 mL Oral Solution) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG / triprolidine HCl 1.25 MG in 10 mL Oral Solution) PackPSNafbe932c-c26a-4fac-9ea3-d050db01eded3
1116572acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 20 mL Oral SolutionPSNafbe932c-c26a-4fac-9ea3-d050db01eded3
2173662acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG / triprolidine HCl 2.5 MG in 20 mL Oral SolutionPSNafbe932c-c26a-4fac-9ea3-d050db01eded3
1116572acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCDafbe932c-c26a-4fac-9ea3-d050db01eded3
2173662acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / phenylephrine hydrochloride 0.5 MG/ML / triprolidine hydrochloride 0.125 MG/ML Oral SolutionSCDafbe932c-c26a-4fac-9ea3-d050db01eded3
26377271 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG / triprolidine HCl 1.25 MG per 10 ML Oral Solution) PackSYafbe932c-c26a-4fac-9ea3-d050db01eded3
1116572acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral SolutionSYafbe932c-c26a-4fac-9ea3-d050db01eded3
2173662acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG / triprolidine hydrochloride 1.25 MG per 10 mL Oral SolutionSYafbe932c-c26a-4fac-9ea3-d050db01eded3
1116572acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine hydrochloride 10 MG per 20 ML Oral SolutionSYafbe932c-c26a-4fac-9ea3-d050db01eded3
2173662acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG / triprolidine hydrochloride 2.5 MG per 20 mL Oral SolutionSYafbe932c-c26a-4fac-9ea3-d050db01eded3
1116572APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / Guaifenesin 20 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral SolutionSYafbe932c-c26a-4fac-9ea3-d050db01eded3
2173662APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML / Triprolidine Hydrochloride 0.125 MG/ML Oral SolutionSYafbe932c-c26a-4fac-9ea3-d050db01eded3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0363-4278-45003634278451 KIT in 1 PACKAGE (0363-4278-45) * 177 mL in 1 BOTTLE, PLASTIC (0363-9042-45) * 177 mL in 1 BOTTLE, PLASTIC (0363-8078-45) 1 kit2023-10-21NoNoCurrent
0363-8078-4500363807845177 mL in 1 BOTTLE, PLASTIC177 mlHistorical
0363-9042-4500363904245177 mL in 1 BOTTLE, PLASTIC177 mlHistorical